Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Orphan Status Granted to Fenfluramine, Asciminib, Vosoritide
The Ministry of Health, Labor and Welfare (MHLW) on August 24 newly granted orphan drug designation to three APIs including Zogenix Japan’s fenfluramine. Fenfluramine was given the status for the proposed indication of epileptic seizures associated with Dravet syndrome. The…
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REGULATORY
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